Director, Clinical Pharmacology

3 weeks ago

BILLERICA, United States Millipore Corporation Full time
Director, Clinical Pharmacology position in Quantitative Pharmacology within the broader Clinical Measurement Sciences organization is a strategic, scientific, and cross-functional role, leading the Clinical Pharmacology (CP) Expert Team, responsible for developing and executing clinical pharmacology and Model Informed Drug Development (MIDD) strategies from the early to late-stage clinical development. This role represents the CP Expert Team to the global cross functional drug discovery and development project teams, in close collaboration with colleagues in Biostatistics, Data Sciences, Clinical Biomarkers and Diagnostics, Research, Clinical Development and other colleagues within the R&D organization. The Director, Clinical Pharmacology provides strong leadership for integrating individual functional contributions, developing clinical pharmacology strategy in alignment with the overall clinical development plan, and executing the program strategy/plan. The scope includes programs from exploratory development (ED) through life cycle management, encompassing large and small molecule therapeutics/drug candidates across different therapeutic areas. Key Accountabilities:Ensures that CP strategy is developed, aligned (with cross-functional development plans), endorsed and executed to support the indication, patient population, and phase of development while taking into account the competitive landscapeRepresent clinical pharmacology and promote MIDD with internal and external stakeholdersProvides in-depth CP, PK and PK/PD advice and expertise and lead clinical pharmacology expert team and deliver onDose and posology decisions, from FIH starting dose through submission and beyondFit-for-purpose CP package including dose, dose regimen, and adjustment for specific conditions and specific populations, exposure-QTc assessment and immunogenicity assessment in collaboration with other function lines at appropriate stages of developmentDevelop and execute MIDD strategies/plans in collaboration with pharmacometrics and other functionsPK/PD data analysis, interpretation, and presentationRelated sections of major clinical and regulatory documents (e.g. clinical protocols, IBs, CTDs, INDs, NDAs, IMPDs, briefing books)Contribute to due diligence projects, if needed Location: Hybrid preferred, Remote possible with travel as required

Who you are:

Minimum Requirements5+ years (Bio)pharmaceutical industry and/or postdoctoral experiences with clinical drug development experienceDoctorate degree (PhD, PharmD or MD) relevant in the related disciplines of clinical pharmacology, pharmaceutics, pharmacometrics, statistics, engineering or mathematicsFluency in English Preferred RequirementsStrong understanding of clinical drug development strategies, and quality related requirements in drug development in GXP-related areas.Deep knowledge in CP, i.e., PK, ADME, posology, quantitative translational sciences, etc.Excellent knowledge of regulatory requirements and submission across the main regionsGood understanding about translational sciences such as quantitative pharmacology, safety and biomarkersClear evidence of ability to adapt to changing business needs by prioritizing multiple tasksGeneral knowledge of oncology, immuno-oncology, and/or immunology, and more in depth understanding of biology and pharmacology is a plusHands on modeling expertise is a plusStrong interpersonal skills and proactivity to cultivate a network of productive relationships in an international matrix environmentDemonstrated ability for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of resultsStrong presentation, communication, and organization skills. Ability to communicate technical results to stakeholdershave a broad scientific understanding across the translational sciences and drug development along with excellent team-building skills and strong collaborative & strategic capabilities

  • Director, Clinical Pharmacology

    3 weeks ago

    Billerica, Massachusetts, United States Millipore Corporation Full time

    Director, Clinical Pharmacology position in Quantitative Pharmacology within the broader Clinical Measurement Sciences organization is a strategic, scientific, and cross-functional role, leading the Clinical Pharmacology (CP) Expert Team, responsible for developing and executing clinical pharmacology and Model Informed Drug Development (MIDD) strategies from...

  • Associate Director, Clinical Pharmacology

    3 weeks ago

    BILLERICA, United States Millipore Corporation Full time

    Associate Director, Clinical Pharmacology position in Quantitative Pharmacology within the broader Clinical Measurement Sciences organization is a strategic, scientific, and cross-functional role, leading the Clinical Pharmacology (CP) Expert Team, responsible for developing and executing clinical pharmacology and Model Informed Drug Development (MIDD)...

  • Associate Director, Clinical Pharmacology

    3 weeks ago

    Billerica, Massachusetts, United States Millipore Corporation Full time

    Associate Director, Clinical Pharmacology position in Quantitative Pharmacology within the broader Clinical Measurement Sciences organization is a strategic, scientific, and cross-functional role, leading the Clinical Pharmacology (CP) Expert Team, responsible for developing and executing clinical pharmacology and Model Informed Drug Development (MIDD)...

  • Vice President, Technical

    3 days ago

    Billerica, United States PAREXEL Full time

    As one of our ex-FDA colleagues describes it: "you get to see a lot of cool stuff very quickly". If you're looking for the opportunity to influence the development strategies of pace-setting biopharma companies, there's no better place to be than as a Vice President, Technical on Parexel's Regulatory Strategy team (RS)! As a VP, Tech you'll work on a variety...

  • Director, Patient-Focused Evidence Global

    3 weeks ago

    Billerica, Massachusetts, United States Millipore Corporation Full time

    As a Director for Patient-Focused Evidence working at a global level, you will lead the development of evidence strategies to capture and integrate the patient's perspective and patient experience data into drug research and development programs to address evidentiary requirements of health authorities and other stakeholders, supporting the end goal of...

  • Director, Patient-Focused Evidence Global

    3 weeks ago

    BILLERICA, United States Millipore Corporation Full time

    As a Director for Patient-Focused Evidence working at a global level, you will lead the development of evidence strategies to capture and integrate the patient's perspective and patient experience data into drug research and development programs to address evidentiary requirements of health authorities and other stakeholders, supporting the end goal of...

  • Director Biostatistician R

    1 month ago

    Billerica, United States EMD Serono Full time

    Work Your Magic with us! Start your next chapter and join EMD Serono. Ready to explore, break barriers, and discover more? We know you've got big plans '“ so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and...

  • Associate Director, Demand Planning

    4 weeks ago

    Billerica, United States Lantheus Holdings, Inc. Full time

    Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing organization that provides...

  • Business Development Director, Biotech West

    3 weeks ago

    Billerica, United States PAREXEL Full time

    Parexel Biotech is dedicated to the biotech industry in supporting our customers with more efficient drug discovery strategies and our regulatory expertise and our support to guide them through an NDA and revenue perspective. We leverage our Subject Matter Experts early in the process to consult with customers to guide them on the right pathway. Our goal is...

  • Associate / Medical Director - Ophthalmology

    1 day ago

    Billerica, MA, United States PAREXEL Full time

    Working at Parexel's Medical Sciences team is about enhancing your understanding of diseases and the drug development process. It's about learning from colleagues with multiple specializations and with experience of how practices vary in different countries. You proudly share your knowledge to grow together and contribute to new successful...

  • Associate Director, Market Access

    7 days ago

    Billerica, United States Lantheus Full time

    Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing organization that provides...

  • Associate Director, Market Access

    2 hours ago

    Billerica, United States Lantheus Medical Imaging Inc Full time

    Job DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing...

  • Associate Director, Market Access

    1 week ago

    Billerica, United States Lantheus Medical Imaging Inc Full time

    Job DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing...

  • Medication Assisted Treatment Clinician

    4 days ago

    Billerica, United States Amergis Full time

    $50 / hour Amergis Healthcare Staffing is seeking a qualified professional for the position of MAT Clinician at the county jail located in Billerica, MA. The MAT Clinician will provide treatment and support to assist patients in their recovery from addiction, assists with modifying problem behaviors; maintains standards of counseling practices in...

  • Medication Assisted Treatment

    3 days ago

    Billerica, United States Middlesex Sheriff's Office Full time

    Job DescriptionJob DescriptionThe Middlesex Sheriff’s Office will be considering applicants for the following employment opportunityMedication Assisted Treatment (“MAT”) ClinicianThe Middlesex Sheriff’s Office (“MSO”) is seeking a qualified professional for the position of MAT Clinician at the Middlesex Jail & House of Correction located in...

  • Mental Health Clinician

    4 weeks ago

    Billerica, United States Middlesex Sheriff's Office Full time

    Mental Health ClinicianThe Middlesex Sheriff's Office (MSO) is seeking a qualified professional for the position of Mental Health Clinician (MHC) to work in the Health Services Unit (HSU) at the Middlesex Jail & House of Correction located in Billerica, MA. The MHC will assess the mental health needs of patients upon commitment to the Middlesex Jail and...

  • Mental Health Clinician

    2 months ago

    Billerica, United States Middlesex Sheriff's Office Full time

    Job DescriptionJob DescriptionMental Health ClinicianThe Middlesex Sheriff’s Office (MSO) is seeking a qualified professional for the position of Mental Health Clinician (MHC) to work in the Health Services Unit (HSU) at the Middlesex Jail & House of Correction located in Billerica, MA.  The MHC will assess the mental health needs of patients upon...

  • Associate Director, Demand Planning

    4 weeks ago

    North Billerica, United States Lantheus Medical Imaging Inc Full time

    Job DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing...

  • Mental Health Clinician

    4 weeks ago

    Billerica, United States Middlesex Sheriff’s Office Full time

    Mental Health ClinicianThe Middlesex Sheriff’s Office (MSO) is seeking a qualified professional for the position of Mental Health Clinician (MHC) to work in the Health Services Unit (HSU) at the Middlesex Jail & House of Correction located in Billerica, MA.  The MHC will assess the mental health needs of patients upon commitment to the Middlesex Jail and...

  • Medication Assisted Treatment

    4 days ago

    Billerica, United States Middlesex Sheriff’s Office Full time

    The Middlesex Sheriff’s Office will be considering applicants for the following employment opportunityMedication Assisted Treatment (“MAT”) ClinicianThe Middlesex Sheriff’s Office (“MSO”) is seeking a qualified professional for the position of MAT Clinician at the Middlesex Jail & House of Correction located in Billerica, MA.  The MAT Clinician...